MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE 6 MM CYLINDRICAL BUR ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number ROB10036

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

Our reference number: case-(b)(4).

Event Description

It was reported that when they burred the distal ap rotation holes on "off" cutting mode during a cori tka procedure, they were using a 6 mm bur and the holes were 5 mm. They forgot that they were still in the "off" mode, and went to check out checkpoints, and then the cori prompted after the femur checkpoint verified, that they were still on "off" (there was a warning that they were still in the "off" mode when they went back to recut). After verifying the checkpoints, they remembered that they were in "off " mode and they switched back to speed control. There was not significant enough bone removed in "off" mode to impact patient outcome during the procedure. No other complications were reported.

• Brand Name: REAL INTELLIGENCE 6 MM CYLINDRICAL BUR
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11319073
• MDR Text Key: 231583775
• Report Number: 3010266064-2021-00098
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: ROB10036
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 02/11/2021 Patient Sequence Number: 1